With year-end temperature drops and increased holiday gatherings requiring extra caution for gout patients, attention is growing toward domestically developed new drugs that could replace existing treatments. JW Pharmaceutical (001060.KS) with its "epaminurad (URC102)," along with candidates from LG Chem (051910.KS) and SK Chemicals (285130.KS), are emerging more than a decade after febuxostat (Feburic) came to dominate the market. Industry observers are watching whether these new drugs can overcome the limitations of existing treatments, including cardiovascular risks and liver toxicity.
According to the pharmaceutical and biotech industry on Wednesday, the domestic gout treatment market has been overwhelmingly dominated by febuxostat, distributed by SK Chemicals, since 2011. Gout is an inflammatory disease that occurs when uric acid in the blood is not properly excreted and accumulates excessively in the body. Treatments work through mechanisms that either inhibit uric acid production or promote uric acid excretion. Febuxostat is a uric acid production inhibitor developed by Japan's Teijin in 2008, appearing approximately 40 years after allopurinol (Zyloprim), the first-line treatment in this category.
The American College of Rheumatology and other bodies recommend allopurinol over febuxostat due to cardiovascular risks. However, in Korea and Japan, febuxostat prescriptions are more common because a higher proportion of patients carry genetic variants that can cause skin adverse reactions when taking allopurinol. Benzbromarone, a uric acid excretion promoter developed in the 1970s, is mainly used when uric acid production inhibitors prove ineffective, due to concerns about liver toxicity and urinary stones.
According to Grand View Research, the global gout treatment market is projected to grow from approximately $2.7 billion last year to $4.1 billion by 2030. In Korea, patient numbers have steadily increased from 468,083 in 2020 to 553,254 in 2023, according to the Health Insurance Review and Assessment Service.
As the market expands, domestic pharmaceutical companies are accelerating development of new treatments. JW Pharmaceutical, LG Chem, and SK Chemicals are each developing new drugs with either uric acid excretion promotion or uric acid production inhibition mechanisms. JW Pharmaceutical is developing epaminurad, which promotes uric acid excretion. The drug demonstrated safety and tolerability in Phase 2 trials, earning assessments of strong "best-in-class" potential. The company aims to complete Phase 3 trials next year and launch as early as 2027, while accelerating global expansion after recently obtaining a U.S. use patent.
LG Chem, which had the fastest development pace, halted global trials for its uric acid production inhibitor "tigulixostat" in March due to commercial viability concerns. However, Chinese partner Innovent Biologics is preparing to enter Phase 3 trials in China. According to Innovent, the candidate showed superior uric acid reduction compared to febuxostat in Phase 2 trials with Chinese patients.
SK Chemicals, the distributor of febuxostat, is conducting Phase 3 trials for "SID2406" as a data-submitted drug (DWLD), with sales potentially starting from 2028 based on the clinical timeline. Industry observers believe the company is working to optimize safety and efficacy by improving febuxostat-based compounds.
"JW Pharmaceutical's epaminurad is undergoing global Phase 3 trials in a head-to-head comparison with febuxostat, which has a different mechanism," an industry official said. "Since most gout patients have reduced uric acid excretion, the goal is to potentially replace the first-line treatment status of uric acid production inhibitors."
The official added: "However, patients with reduced uric acid excretion often respond to uric acid production inhibitors as well, and since drugs in that category have been used as first-line treatments for a long time, there is also potential for use as combination therapy in the future if there are no stability issues."
